Cardiac Pacemakers, Inc. - FDA 510(k) Cleared Devices

Cardiac Pacemakers, Inc. (CPI), doing business as Guidant Cardiac Rhythm Management, manufactured implantable cardiac rhythm management devices. Now part of Boston Scientific, the company is based in Saint Paul, Minnesota, with historical operations in McHenry, US.

The company received 76 FDA 510(k) clearances from 76 total submissions between 1977 and 2010. Cardiovascular devices dominated the regulatory portfolio at 83% of submissions. This historical record reflects the company's core focus on cardiac rhythm management and related interventional technologies.

CPI developed therapies to treat irregular heartbeat through pacemakers, defibrillators, and microprocessor-controlled insulin pumps. The company's cleared devices included pulse generators, lead systems, guide catheters, and specialized surgical instruments for cardiac applications.

This company profile is maintained as a historical regulatory record. Explore the complete list of device names, product codes, and clearance dates in the database.